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Practice Effects May Influence MCI Detection
Failing to account for practice effects may lead to underdiagnosis of mild cognitive impairment (MCI), according to a study published May 14 in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring. In an approximately six-year follow-up of the Vietnam Era Twin Study of Aging, researchers retested the cognitive function of 995 late-middle-aged men. In addition, the researchers tested 170 age-matched study replacements for the first time. The investigators used group differences to calculate practice effects after controlling for attrition effects and generated MCI diagnoses from practice-adjusted scores. There were significant practice effects on most cognitive domains, even though participants’ uncorrected scores may have declined. Conversion to MCI doubled after correcting for practice effects, from 4.5% to 9%.
Elman JA, Jak AJ, Panizzon MS, et al. Underdiagnosis of mild cognitive impairment: a consequence of ignoring practice effects. Alzheimers Dement (Amst). 2018;10:372-381.
Brain Iron Levels Predict Disability in Patients With MS
Iron levels in the brains of patients with multiple sclerosis (MS) measured using quantitative susceptibility mapping (QSM) may help identify people at a higher risk of physical disability, according to a study published online ahead of print July 17 in Radiology. In this prospective study, 600 participants with MS and 250 age- and sex-matched healthy controls were imaged with 3.0-T MRI. The researchers assessed QSM and MRI volumetric differences between study groups and associations with clinical outcomes using analysis of covariance, multivariable linear regression, and voxelwise analyses, controlling for age and sex. Compared with controls, participants with MS had lower thalamic susceptibility and higher susceptibility of basal ganglia. Lower thalamic susceptibility was associated with longer disease duration, greater disability, and secondary-progressive disease course.
Zivadinov R, Tavazzi E, Bergsland N, et al. Brain iron at quantitative MRI is associated with disability in multiple sclerosis. Radiology. 2018 Jul 17 [Epub ahead of print].
Concussion and ADHD May Increase Depression and Anxiety
Athletes with attention deficit hyperactivity disorder (ADHD) may be at greater risk of persistent anxiety and depression after a concussion, compared with athletes without ADHD, according to a study presented at the American Academy of Neurology’s Sports Concussion Conference. The study included 979 NCAA Division I college athletes. Researchers gathered information on ADHD diagnosis and history of concussion, and athletes completed questionnaires measuring anxiety and depression symptoms before the start of their sporting seasons. The investigators divided athletes into four groups—those with ADHD who had had a concussion, those with ADHD who had not had a concussion, those without ADHD who had had a concussion, and those without a history of concussion or ADHD. Athletes with ADHD and concussion had significantly higher anxiety and depression scores, compared with the other groups.
Late-Life Blood Pressure Is Associated With Brain Lesions
Higher average late-life systolic blood pressure and diastolic blood pressure are associated with an increasing number of brain infarcts, including gross and microinfarcts, according to a study published online ahead of print July 11 in Neurology. In addition, faster decline in systolic blood pressure increases the likelihood of an infarct. This clinical-pathologic study included data from 1,288 people who participated in prospective, community-based cohort studies of aging with similar designs and data collection. Blood pressure measurements were obtained annually. Participants were followed for an average of eight years, and the average age at death was 89. The mean standardized person-specific systolic blood pressure was 134 mm Hg and diastolic blood pressure was 71 mm Hg. Alzheimer’s disease pathology analyses found that systolic blood pressure was associated with the number of tangles but not plaques or other pathology.
Arvanitakis Z, Capuano AW, Lamar M, et al. Late-life blood pressure association with cerebrovascular and Alzheimer disease pathology. Neurology. 2018 Jul 11 [Epub ahead of print].
Is t-PA Beneficial for Minor Stroke?
Among patients with mild acute ischemic stroke, treatment with alteplase does not increase the likelihood of favorable functional outcome at 90 days, compared with treatment with aspirin, according to a study published July 10 in JAMA. The PRISMS trial, a phase IIIb, double-blind, double-placebo, randomized clinical trial, compared alteplase with aspirin for the treatment of emergent stroke. The study enrolled patients with NIH Stroke Scale scores of 0 to 5 and deficits that were not clearly disabling. Eligible patients were able to receive treatment within three hours of onset. Participants were randomized to receive IV alteplase (0.9 mg/kg) with oral placebo (n = 156) or oral aspirin (325 mg) with IV placebo (n = 157). At 90 days, 78.2% of patients in the alteplase group and 81.5% of patients in the aspirin group had a favorable outcome (ie, a modified Rankin Scale score of 0 or 1). The trial originally was designed to enroll 948 patients but was ended early because of slow enrollment. The early study termination precludes definitive conclusions, the investigators said.
Khatri P, Kleindorfer DO, Devlin T, et al. Effect of alteplase vs aspirin on functional outcome for patients with acute ischemic stroke and minor nondisabling neurologic deficits: the PRISMS randomized clinical trial. JAMA. 2018 Jul 10;320(2):156-166.
FDA Approves Xeomin for Adults With Sialorrhea
The FDA has approved the supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea in adult patients. The approval was based on a phase III, randomized, double-blind, placebo-controlled, multicenter trial that included 184 patients. The coprimary end points of change in unstimulated salivary flow rate and Global Impression of Change Scale at week four as compared with baseline significantly improved for participants administered 100 U incobotulinumtoxinA versus placebo. The overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Participants in the study received placebo, incobotulinumtoxinA 75 U, or incobotulinumtoxinA 100 U. Merz North America, which markets Xeomin, is headquartered in Raleigh, North Carolina.
Does Exposure to Organic Solvents Heighten the Risk of MS?
People who are exposed to organic solvents and carry genes that make them more susceptible to developing multiple sclerosis (MS) may be at greater risk of the disease than people who have only the exposure to solvents or the MS risk genes, according to a study published online ahead of print July 3 in Neurology. Using a Swedish population-based case–control study of 2,042 incident cases of MS and 2,947 controls, investigators compared the occurrence of MS in participants with different genotypes, smoking habits, and exposures to organic solvents such as paint and varnish. A potential interaction between exposure to organic solvents and MS risk human leukocyte antigen genes was evaluated by calculating the attributable proportion due to interaction. The MS genes and exposure to solvents combined were responsible for an estimated 60% of the risk of developing MS.
Hedström AK, Hössjer O, Katsoulis M, et al. Organic solvents and MS susceptibility: interaction with MS risk HLA genes. Neurology. 2018 Jul 3 [Epub ahead of print].
Epidiolex Approved for the Treatment of Seizures
The FDA approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients age 2 and older. Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It also is the first FDA approval of a drug for the treatment of patients with Dravet syndrome. The drug’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials that included 516 patients with Lennox-Gastaut syndrome or Dravet syndrome. Taken with other medications, cannabidiol reduced the frequency of seizures, compared with placebo. Epidiolex must be dispensed with a patient medication guide that describes the drug’s uses and risks. GW Pharmaceuticals, located in the United Kingdom, markets Epidiolex.
FDA Approves Nuplazid Capsule Formulation and 10-mg Tablet
The FDA approved a new capsule dose formulation and tablet strength of Nuplazid (pimavanserin), a treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. The 34-mg capsule formulation provides the recommended once daily dose in one capsule, versus the current administration of two 17-mg tablets. The 10-mg tablet provides a lower dosage strength for patients who are concomitantly receiving strong cytochrome 3A4 inhibitors, which can inhibit the metabolism of Nuplazid. The drug is a nondopaminergic, selective serotonin inverse agonist preferentially targeting 5-HT2A receptors. Acadia Pharmaceuticals, which markets the therapy, is headquartered in San Diego.
Mild Sleep Problems May Elevate Blood Pressure in Women
Mild sleep problems such as trouble falling asleep are associated with increased blood pressure and vascular inflammation in women, according to a study published June 9 in the Journal of the American Heart Association. Researchers examined blood pressure and sleep habits in 323 women in the ongoing American Heart Association Go Red for Women Strategically Focused Research Network. Investigators assessed participant’s sleep quality, obstructive sleep apnea risk, and insomnia severity. In a subset of women, sleep duration was assessed using actigraphy, and endothelial inflammation was assessed directly in harvested endothelial cells. Systolic blood pressure was associated with poor sleep quality. Poor sleep quality, insomnia, and longer sleep onset latency were associated with endothelial inflammation.
Aggarwal B, Makarem N, Shah R, et al. Effects of inadequate sleep on blood pressure and endothelial inflammation in women: findings from the American Heart Association Go Red for Women Strategically Focused Research Network. J Am Heart Assoc. 2018;7(12):e008590.
DBS May Slow Tremor Progression in Early Parkinson’s Disease
Deep brain stimulation (DBS) in the early stage of Parkinson’s disease may slow tremor progression, according to a study published online ahead of print June 29 in Neurology. The prospective pilot trial enrolled patients with Parkinson’s disease who were ages 50 to 75, had been treated with Parkinson’s disease medications for six months to four years, and had no history of dyskinesia or other motor fluctuations. Participants were randomized to receive optimal drug therapy (ODT) or DBS and ODT. At baseline and six, 12, 18, and 24 months, all patients stopped all Parkinson’s disease therapy for one week. Unified Parkinson’s Disease Rating Scale-III scores were compared between the ODT and DBS and ODT groups (n = 28). Rest tremor slopes from baseline to 24 months favored DBS plus ODT off and on therapy, compared with ODT alone.
Hacker ML, DeLong MR, Turchan M, et al. Effects of deep brain stimulation on rest tremor progression in early stage Parkinson disease. Neurology. 2018 Jun 29 [Epub ahead of print].
—Kimberly Williams
Practice Effects May Influence MCI Detection
Failing to account for practice effects may lead to underdiagnosis of mild cognitive impairment (MCI), according to a study published May 14 in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring. In an approximately six-year follow-up of the Vietnam Era Twin Study of Aging, researchers retested the cognitive function of 995 late-middle-aged men. In addition, the researchers tested 170 age-matched study replacements for the first time. The investigators used group differences to calculate practice effects after controlling for attrition effects and generated MCI diagnoses from practice-adjusted scores. There were significant practice effects on most cognitive domains, even though participants’ uncorrected scores may have declined. Conversion to MCI doubled after correcting for practice effects, from 4.5% to 9%.
Elman JA, Jak AJ, Panizzon MS, et al. Underdiagnosis of mild cognitive impairment: a consequence of ignoring practice effects. Alzheimers Dement (Amst). 2018;10:372-381.
Brain Iron Levels Predict Disability in Patients With MS
Iron levels in the brains of patients with multiple sclerosis (MS) measured using quantitative susceptibility mapping (QSM) may help identify people at a higher risk of physical disability, according to a study published online ahead of print July 17 in Radiology. In this prospective study, 600 participants with MS and 250 age- and sex-matched healthy controls were imaged with 3.0-T MRI. The researchers assessed QSM and MRI volumetric differences between study groups and associations with clinical outcomes using analysis of covariance, multivariable linear regression, and voxelwise analyses, controlling for age and sex. Compared with controls, participants with MS had lower thalamic susceptibility and higher susceptibility of basal ganglia. Lower thalamic susceptibility was associated with longer disease duration, greater disability, and secondary-progressive disease course.
Zivadinov R, Tavazzi E, Bergsland N, et al. Brain iron at quantitative MRI is associated with disability in multiple sclerosis. Radiology. 2018 Jul 17 [Epub ahead of print].
Concussion and ADHD May Increase Depression and Anxiety
Athletes with attention deficit hyperactivity disorder (ADHD) may be at greater risk of persistent anxiety and depression after a concussion, compared with athletes without ADHD, according to a study presented at the American Academy of Neurology’s Sports Concussion Conference. The study included 979 NCAA Division I college athletes. Researchers gathered information on ADHD diagnosis and history of concussion, and athletes completed questionnaires measuring anxiety and depression symptoms before the start of their sporting seasons. The investigators divided athletes into four groups—those with ADHD who had had a concussion, those with ADHD who had not had a concussion, those without ADHD who had had a concussion, and those without a history of concussion or ADHD. Athletes with ADHD and concussion had significantly higher anxiety and depression scores, compared with the other groups.
Late-Life Blood Pressure Is Associated With Brain Lesions
Higher average late-life systolic blood pressure and diastolic blood pressure are associated with an increasing number of brain infarcts, including gross and microinfarcts, according to a study published online ahead of print July 11 in Neurology. In addition, faster decline in systolic blood pressure increases the likelihood of an infarct. This clinical-pathologic study included data from 1,288 people who participated in prospective, community-based cohort studies of aging with similar designs and data collection. Blood pressure measurements were obtained annually. Participants were followed for an average of eight years, and the average age at death was 89. The mean standardized person-specific systolic blood pressure was 134 mm Hg and diastolic blood pressure was 71 mm Hg. Alzheimer’s disease pathology analyses found that systolic blood pressure was associated with the number of tangles but not plaques or other pathology.
Arvanitakis Z, Capuano AW, Lamar M, et al. Late-life blood pressure association with cerebrovascular and Alzheimer disease pathology. Neurology. 2018 Jul 11 [Epub ahead of print].
Is t-PA Beneficial for Minor Stroke?
Among patients with mild acute ischemic stroke, treatment with alteplase does not increase the likelihood of favorable functional outcome at 90 days, compared with treatment with aspirin, according to a study published July 10 in JAMA. The PRISMS trial, a phase IIIb, double-blind, double-placebo, randomized clinical trial, compared alteplase with aspirin for the treatment of emergent stroke. The study enrolled patients with NIH Stroke Scale scores of 0 to 5 and deficits that were not clearly disabling. Eligible patients were able to receive treatment within three hours of onset. Participants were randomized to receive IV alteplase (0.9 mg/kg) with oral placebo (n = 156) or oral aspirin (325 mg) with IV placebo (n = 157). At 90 days, 78.2% of patients in the alteplase group and 81.5% of patients in the aspirin group had a favorable outcome (ie, a modified Rankin Scale score of 0 or 1). The trial originally was designed to enroll 948 patients but was ended early because of slow enrollment. The early study termination precludes definitive conclusions, the investigators said.
Khatri P, Kleindorfer DO, Devlin T, et al. Effect of alteplase vs aspirin on functional outcome for patients with acute ischemic stroke and minor nondisabling neurologic deficits: the PRISMS randomized clinical trial. JAMA. 2018 Jul 10;320(2):156-166.
FDA Approves Xeomin for Adults With Sialorrhea
The FDA has approved the supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea in adult patients. The approval was based on a phase III, randomized, double-blind, placebo-controlled, multicenter trial that included 184 patients. The coprimary end points of change in unstimulated salivary flow rate and Global Impression of Change Scale at week four as compared with baseline significantly improved for participants administered 100 U incobotulinumtoxinA versus placebo. The overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Participants in the study received placebo, incobotulinumtoxinA 75 U, or incobotulinumtoxinA 100 U. Merz North America, which markets Xeomin, is headquartered in Raleigh, North Carolina.
Does Exposure to Organic Solvents Heighten the Risk of MS?
People who are exposed to organic solvents and carry genes that make them more susceptible to developing multiple sclerosis (MS) may be at greater risk of the disease than people who have only the exposure to solvents or the MS risk genes, according to a study published online ahead of print July 3 in Neurology. Using a Swedish population-based case–control study of 2,042 incident cases of MS and 2,947 controls, investigators compared the occurrence of MS in participants with different genotypes, smoking habits, and exposures to organic solvents such as paint and varnish. A potential interaction between exposure to organic solvents and MS risk human leukocyte antigen genes was evaluated by calculating the attributable proportion due to interaction. The MS genes and exposure to solvents combined were responsible for an estimated 60% of the risk of developing MS.
Hedström AK, Hössjer O, Katsoulis M, et al. Organic solvents and MS susceptibility: interaction with MS risk HLA genes. Neurology. 2018 Jul 3 [Epub ahead of print].
Epidiolex Approved for the Treatment of Seizures
The FDA approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients age 2 and older. Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It also is the first FDA approval of a drug for the treatment of patients with Dravet syndrome. The drug’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials that included 516 patients with Lennox-Gastaut syndrome or Dravet syndrome. Taken with other medications, cannabidiol reduced the frequency of seizures, compared with placebo. Epidiolex must be dispensed with a patient medication guide that describes the drug’s uses and risks. GW Pharmaceuticals, located in the United Kingdom, markets Epidiolex.
FDA Approves Nuplazid Capsule Formulation and 10-mg Tablet
The FDA approved a new capsule dose formulation and tablet strength of Nuplazid (pimavanserin), a treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. The 34-mg capsule formulation provides the recommended once daily dose in one capsule, versus the current administration of two 17-mg tablets. The 10-mg tablet provides a lower dosage strength for patients who are concomitantly receiving strong cytochrome 3A4 inhibitors, which can inhibit the metabolism of Nuplazid. The drug is a nondopaminergic, selective serotonin inverse agonist preferentially targeting 5-HT2A receptors. Acadia Pharmaceuticals, which markets the therapy, is headquartered in San Diego.
Mild Sleep Problems May Elevate Blood Pressure in Women
Mild sleep problems such as trouble falling asleep are associated with increased blood pressure and vascular inflammation in women, according to a study published June 9 in the Journal of the American Heart Association. Researchers examined blood pressure and sleep habits in 323 women in the ongoing American Heart Association Go Red for Women Strategically Focused Research Network. Investigators assessed participant’s sleep quality, obstructive sleep apnea risk, and insomnia severity. In a subset of women, sleep duration was assessed using actigraphy, and endothelial inflammation was assessed directly in harvested endothelial cells. Systolic blood pressure was associated with poor sleep quality. Poor sleep quality, insomnia, and longer sleep onset latency were associated with endothelial inflammation.
Aggarwal B, Makarem N, Shah R, et al. Effects of inadequate sleep on blood pressure and endothelial inflammation in women: findings from the American Heart Association Go Red for Women Strategically Focused Research Network. J Am Heart Assoc. 2018;7(12):e008590.
DBS May Slow Tremor Progression in Early Parkinson’s Disease
Deep brain stimulation (DBS) in the early stage of Parkinson’s disease may slow tremor progression, according to a study published online ahead of print June 29 in Neurology. The prospective pilot trial enrolled patients with Parkinson’s disease who were ages 50 to 75, had been treated with Parkinson’s disease medications for six months to four years, and had no history of dyskinesia or other motor fluctuations. Participants were randomized to receive optimal drug therapy (ODT) or DBS and ODT. At baseline and six, 12, 18, and 24 months, all patients stopped all Parkinson’s disease therapy for one week. Unified Parkinson’s Disease Rating Scale-III scores were compared between the ODT and DBS and ODT groups (n = 28). Rest tremor slopes from baseline to 24 months favored DBS plus ODT off and on therapy, compared with ODT alone.
Hacker ML, DeLong MR, Turchan M, et al. Effects of deep brain stimulation on rest tremor progression in early stage Parkinson disease. Neurology. 2018 Jun 29 [Epub ahead of print].
—Kimberly Williams
Practice Effects May Influence MCI Detection
Failing to account for practice effects may lead to underdiagnosis of mild cognitive impairment (MCI), according to a study published May 14 in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring. In an approximately six-year follow-up of the Vietnam Era Twin Study of Aging, researchers retested the cognitive function of 995 late-middle-aged men. In addition, the researchers tested 170 age-matched study replacements for the first time. The investigators used group differences to calculate practice effects after controlling for attrition effects and generated MCI diagnoses from practice-adjusted scores. There were significant practice effects on most cognitive domains, even though participants’ uncorrected scores may have declined. Conversion to MCI doubled after correcting for practice effects, from 4.5% to 9%.
Elman JA, Jak AJ, Panizzon MS, et al. Underdiagnosis of mild cognitive impairment: a consequence of ignoring practice effects. Alzheimers Dement (Amst). 2018;10:372-381.
Brain Iron Levels Predict Disability in Patients With MS
Iron levels in the brains of patients with multiple sclerosis (MS) measured using quantitative susceptibility mapping (QSM) may help identify people at a higher risk of physical disability, according to a study published online ahead of print July 17 in Radiology. In this prospective study, 600 participants with MS and 250 age- and sex-matched healthy controls were imaged with 3.0-T MRI. The researchers assessed QSM and MRI volumetric differences between study groups and associations with clinical outcomes using analysis of covariance, multivariable linear regression, and voxelwise analyses, controlling for age and sex. Compared with controls, participants with MS had lower thalamic susceptibility and higher susceptibility of basal ganglia. Lower thalamic susceptibility was associated with longer disease duration, greater disability, and secondary-progressive disease course.
Zivadinov R, Tavazzi E, Bergsland N, et al. Brain iron at quantitative MRI is associated with disability in multiple sclerosis. Radiology. 2018 Jul 17 [Epub ahead of print].
Concussion and ADHD May Increase Depression and Anxiety
Athletes with attention deficit hyperactivity disorder (ADHD) may be at greater risk of persistent anxiety and depression after a concussion, compared with athletes without ADHD, according to a study presented at the American Academy of Neurology’s Sports Concussion Conference. The study included 979 NCAA Division I college athletes. Researchers gathered information on ADHD diagnosis and history of concussion, and athletes completed questionnaires measuring anxiety and depression symptoms before the start of their sporting seasons. The investigators divided athletes into four groups—those with ADHD who had had a concussion, those with ADHD who had not had a concussion, those without ADHD who had had a concussion, and those without a history of concussion or ADHD. Athletes with ADHD and concussion had significantly higher anxiety and depression scores, compared with the other groups.
Late-Life Blood Pressure Is Associated With Brain Lesions
Higher average late-life systolic blood pressure and diastolic blood pressure are associated with an increasing number of brain infarcts, including gross and microinfarcts, according to a study published online ahead of print July 11 in Neurology. In addition, faster decline in systolic blood pressure increases the likelihood of an infarct. This clinical-pathologic study included data from 1,288 people who participated in prospective, community-based cohort studies of aging with similar designs and data collection. Blood pressure measurements were obtained annually. Participants were followed for an average of eight years, and the average age at death was 89. The mean standardized person-specific systolic blood pressure was 134 mm Hg and diastolic blood pressure was 71 mm Hg. Alzheimer’s disease pathology analyses found that systolic blood pressure was associated with the number of tangles but not plaques or other pathology.
Arvanitakis Z, Capuano AW, Lamar M, et al. Late-life blood pressure association with cerebrovascular and Alzheimer disease pathology. Neurology. 2018 Jul 11 [Epub ahead of print].
Is t-PA Beneficial for Minor Stroke?
Among patients with mild acute ischemic stroke, treatment with alteplase does not increase the likelihood of favorable functional outcome at 90 days, compared with treatment with aspirin, according to a study published July 10 in JAMA. The PRISMS trial, a phase IIIb, double-blind, double-placebo, randomized clinical trial, compared alteplase with aspirin for the treatment of emergent stroke. The study enrolled patients with NIH Stroke Scale scores of 0 to 5 and deficits that were not clearly disabling. Eligible patients were able to receive treatment within three hours of onset. Participants were randomized to receive IV alteplase (0.9 mg/kg) with oral placebo (n = 156) or oral aspirin (325 mg) with IV placebo (n = 157). At 90 days, 78.2% of patients in the alteplase group and 81.5% of patients in the aspirin group had a favorable outcome (ie, a modified Rankin Scale score of 0 or 1). The trial originally was designed to enroll 948 patients but was ended early because of slow enrollment. The early study termination precludes definitive conclusions, the investigators said.
Khatri P, Kleindorfer DO, Devlin T, et al. Effect of alteplase vs aspirin on functional outcome for patients with acute ischemic stroke and minor nondisabling neurologic deficits: the PRISMS randomized clinical trial. JAMA. 2018 Jul 10;320(2):156-166.
FDA Approves Xeomin for Adults With Sialorrhea
The FDA has approved the supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea in adult patients. The approval was based on a phase III, randomized, double-blind, placebo-controlled, multicenter trial that included 184 patients. The coprimary end points of change in unstimulated salivary flow rate and Global Impression of Change Scale at week four as compared with baseline significantly improved for participants administered 100 U incobotulinumtoxinA versus placebo. The overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Participants in the study received placebo, incobotulinumtoxinA 75 U, or incobotulinumtoxinA 100 U. Merz North America, which markets Xeomin, is headquartered in Raleigh, North Carolina.
Does Exposure to Organic Solvents Heighten the Risk of MS?
People who are exposed to organic solvents and carry genes that make them more susceptible to developing multiple sclerosis (MS) may be at greater risk of the disease than people who have only the exposure to solvents or the MS risk genes, according to a study published online ahead of print July 3 in Neurology. Using a Swedish population-based case–control study of 2,042 incident cases of MS and 2,947 controls, investigators compared the occurrence of MS in participants with different genotypes, smoking habits, and exposures to organic solvents such as paint and varnish. A potential interaction between exposure to organic solvents and MS risk human leukocyte antigen genes was evaluated by calculating the attributable proportion due to interaction. The MS genes and exposure to solvents combined were responsible for an estimated 60% of the risk of developing MS.
Hedström AK, Hössjer O, Katsoulis M, et al. Organic solvents and MS susceptibility: interaction with MS risk HLA genes. Neurology. 2018 Jul 3 [Epub ahead of print].
Epidiolex Approved for the Treatment of Seizures
The FDA approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients age 2 and older. Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It also is the first FDA approval of a drug for the treatment of patients with Dravet syndrome. The drug’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials that included 516 patients with Lennox-Gastaut syndrome or Dravet syndrome. Taken with other medications, cannabidiol reduced the frequency of seizures, compared with placebo. Epidiolex must be dispensed with a patient medication guide that describes the drug’s uses and risks. GW Pharmaceuticals, located in the United Kingdom, markets Epidiolex.
FDA Approves Nuplazid Capsule Formulation and 10-mg Tablet
The FDA approved a new capsule dose formulation and tablet strength of Nuplazid (pimavanserin), a treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. The 34-mg capsule formulation provides the recommended once daily dose in one capsule, versus the current administration of two 17-mg tablets. The 10-mg tablet provides a lower dosage strength for patients who are concomitantly receiving strong cytochrome 3A4 inhibitors, which can inhibit the metabolism of Nuplazid. The drug is a nondopaminergic, selective serotonin inverse agonist preferentially targeting 5-HT2A receptors. Acadia Pharmaceuticals, which markets the therapy, is headquartered in San Diego.
Mild Sleep Problems May Elevate Blood Pressure in Women
Mild sleep problems such as trouble falling asleep are associated with increased blood pressure and vascular inflammation in women, according to a study published June 9 in the Journal of the American Heart Association. Researchers examined blood pressure and sleep habits in 323 women in the ongoing American Heart Association Go Red for Women Strategically Focused Research Network. Investigators assessed participant’s sleep quality, obstructive sleep apnea risk, and insomnia severity. In a subset of women, sleep duration was assessed using actigraphy, and endothelial inflammation was assessed directly in harvested endothelial cells. Systolic blood pressure was associated with poor sleep quality. Poor sleep quality, insomnia, and longer sleep onset latency were associated with endothelial inflammation.
Aggarwal B, Makarem N, Shah R, et al. Effects of inadequate sleep on blood pressure and endothelial inflammation in women: findings from the American Heart Association Go Red for Women Strategically Focused Research Network. J Am Heart Assoc. 2018;7(12):e008590.
DBS May Slow Tremor Progression in Early Parkinson’s Disease
Deep brain stimulation (DBS) in the early stage of Parkinson’s disease may slow tremor progression, according to a study published online ahead of print June 29 in Neurology. The prospective pilot trial enrolled patients with Parkinson’s disease who were ages 50 to 75, had been treated with Parkinson’s disease medications for six months to four years, and had no history of dyskinesia or other motor fluctuations. Participants were randomized to receive optimal drug therapy (ODT) or DBS and ODT. At baseline and six, 12, 18, and 24 months, all patients stopped all Parkinson’s disease therapy for one week. Unified Parkinson’s Disease Rating Scale-III scores were compared between the ODT and DBS and ODT groups (n = 28). Rest tremor slopes from baseline to 24 months favored DBS plus ODT off and on therapy, compared with ODT alone.
Hacker ML, DeLong MR, Turchan M, et al. Effects of deep brain stimulation on rest tremor progression in early stage Parkinson disease. Neurology. 2018 Jun 29 [Epub ahead of print].
—Kimberly Williams
